• Exit of the United Kingdom from the European Union has implications on the medical device and IVD industry. The post-Brexit medical device regulations released by the UK MHRA mandated that all the foreign medical devices and IVD companies to appoint a United Kingdom Responsible Person (UKRP) to act on their behalf.

    As a result of the UK MHRA mandate, starting from January 01, 2021, the manufacturers have already been appointing the UK Responsible Person as per the four (04) months, eight (08) months and 12 months’ transition timelines for various device categories. Though appointing a UK Responsible Person sounds like a one-time activity, there are various aspects to be taken care from time to time post the appointment.

    UKRP Appointed - What’s Next?
  • Overview

    United Kingdom Responsible Person (UKRP) plays a major role in representing a non-UK manufacturer and their medical device product with the Medicines and Healthcare Products Regulatory Agency (MHRA). The UKRP, who is responsible for registration of devices with the MHRA, shall:

    5 Steps for Appointing a UK Responsible Person (UKRP)
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